Supporting participants with severe mental illness and associated cognitive deficits to engage in physical activity and sedentary behaviour research

Purpose: The Walking for Health (WORtH) study is a feasibility randomised controlled trial of a multi-component behaviour change intervention to support adults with severe mental illness (SMI) to increase their physical activity and reduce their sedentary behaviour(McDonough2021). People with SMI can experience deficits in several cognitive domains. When this was observed to influence participants’ engagement with the WORtH study, modifications were made to support their engagement with outcome assessment and intervention delivery.
Methods: The WORtH study was conducted over a series of recruitment waves. A record was maintained of observations related to participant engagement. This record was supplemented by qualitative interviews with participants and the clinicians delivering the intervention. Findings were presented to the trial management group to identify modifications to procedures that were implemented in the subsequent recruitment wave.
Findings: Observations from the first wave (n=9 participants) included the requirement for increased support from the clinical and research team to engage with intervention delivery, e.g., with scheduling and completing study materials, and both quantitative and qualitative outcome assessment, e.g., with completing paper-based assessments. Since cognitive function may have influenced participants’ engagement with the study, the Montreal Cognitive Assessment – Blind version was added to the baseline assessment as a potential explanatory measure. Other modifications included: shorter study sessions; appointment reminders; additional written study materials and instructions; and telephone support. Changes to the qualitative data collection included: inperson interviews, when possible; giving participants a summary of interview questions in advance; providing visual cues of the study components; and use of more closed questions and member checking. Service user involvement supported amendments to intervention delivery, including format of the education session to improve engagement, provision of additional study materials and training support for participants.
Conclusions: Delivering and evaluating physical activity and sedentary behaviour interventions with people with SMI can present challenges, and researchers need to be flexible and responsive in delivery. Ongoing dialogue with participants and other stakeholders is important to ensure appropriate modifications. The modifications detailed have enhanced the project to improve participant engagement with intervention delivery and outcome assessment and may be valuable for future research in this area.